Parenteral fluid administration equipment



Jan. 24, 1961 ll /4 a c. R. BROMAN 2,969,063

PARENTERAL FLUID ADMINISTRATION EQUIPMENT Filed Feb. 10, 1958//VVE/VTOR-' lav 19M zhmtw ATTORNEYS.

Unite PARENTERAL FLUID ADMINISTRATION EQUIPMENT Cyrus R. Broman,Evanston, 111., assignor to Baxter Laboratories, llnc., Morton Grove,111., a corporation of Delaware Filed Feb. 10, 1958, Ser. No. 714,422

10 Claims. (Cl. 128-214) ume and the entire contents of a bottle may beadministered to an adult patient over a period of several hours. Where asmaller quantity than the entire contents of the container is desired tobe administered, close personal supervision is required, and even then,there is no guarantee that the prescribed lesser amount is given.

For example, when treating infants with a parenteral solution, is itdesirable to be able to quickly administer smaller amounts from a bulkparenteral solution, with confidence that no excess is given. A devicefor that purpose is shown in the co-owned copending application of Theodore H. Gewecke, Serial No. 561,461, filed January 26, 1956, andreference is hereby made to that application.

There is a need, however, to be able to administer smaller amounts froma bulk parenteral source where the smaller amounts themselves aredispensed in increments. To fully meet this need, it is necessary thatthe increments be dispensed either simultaneously or sequentially.

It is a general object of this invention to provide a de vice that meetsthe need set forth above. Another object is to provide a device forsequentially delivering equal amounts of a parenteral fluid from a fluidsource to a tube and needle administration set. Still another object isto provide a device that permits administration of a predeterminedquantity of parenteral fluid in equal increments. Other objects andadvantages of this invention can be seen as this specification proceeds.

This invention will be explained, in an illustrative embodiment, inconjunction with the accompanying draw ing, in which- Fig. 1 is aperspective view of the device of this invention shown in combinationwith a parenteral solution bottle and a tube and needle administrationset; Fig. 2 is an enlarged front elevational View of the device shown inFig. l; and Fig. 3 is an enlarged cross-sectional view taken alonjq theline 3--3 of Fig. 2.

In the illustration given, the numeral designates generally a bulkparenteral solution container which usually takes the form of a glassbottle equipped with a suitable closure 11 and suspending meansgenerally designated 12. Through the use of suspending means 12, whichincludes a band 13 mounted in an annular recess 14 ad jacent the bottomof bottle 10, and a bail 15, bottle 10 can be supported from a hook 16or like means. All of the foregoing is well known to those skilled inthe art, so

further details of the construction and arrangement of a tates Patentbulk parenteral solution container is deemed unnecessary. Also, it iswell known to provide closure 11 with a passage extending therethroughwhich permits the dispensing of the liquid contents 16 of bottle 10 whenthe bottle 10 is mounted in a mouth-downward condition as shown. Thedispensing ordinarily is performed through a tube and needle set, whichis designated in Fig. 1 generally by the numeral 17.

Administration set 17 is seen to include a length of flexible tubing 18equipped at one end with a hypodermic needle 19 intended to be insertedbeneath the skin of a recipient and at the other end with a drip meter20. The upper end of dripmeter 20 is equipped with a plug-in connector(shown in dotted lines) and designated 21, which, when the device 22 ofthis invention is not employed, is inserted into the above mentionedpassage in closure 11.

The device 22 includes an elongated tubular envelope equipped with aflow port 23 at the upper end thereof and an analogous flow port 24 atthe bottom end thereof. Device 22 may be constructed of a flexible,translucent plastic resinous material such as polyvinyl chloride.Preferably, a thermoplastic material is employed for this purpose so asto permit a construction of the envelope by heat-sealing two sheets offlat material along the longer edges thereof. In this respect, thedevice here presented partakes of the nature of the device described inthe above mentioned application of Theodore H. Gewecke.

Device 22 is equipped with a plurality of neck-like portions 25 disposedintermediate flow ports 23 and 24. Neck-like constricted portions 25 areprovided by notching-out :at corresponding opposed portions the twosheets of thermoplastic material which are employed to form the lay-flatenvelope included within device 22. An envelope of the character shownin Figs. 1 and 2lcan be conveniently constructed in a singleheat-sealing and diecutting operation by placing two flat, flexiblesheets of translucent thermoplastic material in face-to-face relationand then bringing mating dies together while on opposite sides of theface-to-face sheets. The die-defining edges can be suitably energizedwith electrical energy so as to fuse edge portions of the two sheetstogether while at the same time weakening the sheets outside the fusededges so as to permit detachment of the formed envelope from the parentsheets.

Excellent results are obtained when the constricted portions 25 arespaced apart in a manner that gradually diminishes from the top to thebottom of the device 22. The decrease in spacing is represented in Fig.2 by the dimension arrows about the letters A, B, C, D and E. Forexample, in a device capable of holding 50 ml. of a parenteral fluid,the dimensions identified above by letter may take the following values:

TABLE Letter: Value, inches 1 C 1 D 1% E 1 By the foregoing variation inthe height of the various chambers 26 included between adjacentconstricted portions 25, the difference in hydrostatic head on adjacentchambers is compensated for.

The lower end of device 22 is equipped with a tubular outlet 27 whichmay be conveniently constructed of a thermoplastic flexible material andheat-sealed to the main body of the device as at 28. United to conduit27 as by solvent sealing is a second conduit 29 which prior to use isclosed by a sleeve-type of stopper cap 30.

The upper end of device 22 is coupled to a flow conduit 31 by means of aheat-seal 32, much the same as conduit 27 is attached by means ofheat-seal 28 to the lower end of device 22. The upp r end of conduit 31receives a rigid plastic plug-in connector 33 which is adapted to beinserted into the passageway of closure 11 as seen in Fig. 1. Prior touse, connector 33 is provided with a protector 34 which is essentially asleeve of flexible plastic material closed at one end by a cotton plug35 and equipped at the other end with a pull-tab 36. Disposedintermediate the ends of conduit 31 is a resilient rubber connector 36which may be employed for the introduction of supplemental medicationinasmuch as the resilient nature of the rubber material of which theconnector 36 is constructed permits it to reseal itself after punctureby a hypodermic needle. To establish suitable connections betweenconnector 36 and the two portions of conduit 31 shown in Fig. 2,polyethylene bushings (shown in dotted lines) and designated 37 may beemployed.

It is believed that a brief description of the use of device 22 in atypical environment will be helpful for the further understanding ofthis invention, and for such purpose the following is set forth:

Operation In the employment of the device 22 in the parenteral solutionadministration set-up pictured in Fig. 1, the stopper 30' and protector34 are first removed from the device 22. Thereafter, connector 33 isinserted into a previously provided passageway in closure 11 andconnector 21 of drip device 20 is is inserted into conduit 29. A rollerclamp 38 provided on tubing 18 is then closed and bottle inverted andsuspended as shown in Fig. 1. At this moment, device 22 is in asubstantially flat condition and devoid of any air. Upon the inversionof bottle 10, liquid flows through connector 33 and port 23 into device22 to fill the same. The bottom end of device 22 is effectively closedby the quantity of air in drip housing 20 which cannot escape upwardlythrough the column of liquid in bottle 10 and device 22, nor downwardlybecause of the closed condition of clamp 38. Thus, in effect, device 22becomes an extension of bottle 10. The liquid exiting from bottle 10 tofill device 22 is replaced by air entering bottle 10 from the outside toair tube 39.

Thereafter, administration set 17 is filled in a conventional manner andthe drip level in drip housing 20 also provided. In the illustrationgiven, this can be done by milking or pumping the resilient lowerclosure 20a of drip housing 20 to force air therefrom upwardly through.device 22 and into bottle 10 and be replaced with liquid from bottle 10.When about half of the air from drip device 20 has been so replaced, asuitable drip level is established and further pumping of end closure20a is stopped. Thereafter, clamp 38 is opened and liquid from dripdevice 20 is allowed to fill tubing 18 and needle 19, purging the set ofair. As liquid flows out of drip device 20 for this purpose, it issimultaneously replaced with liquid from bottle 10 flowing throughdevice 22. When the entire set 17 is purged of air except for the airpocket remaining in drip device 20 needed for the maintenance of a driplevel, clamp 38 is once again closed and the entire system is ready foruse.

At this point, it is possible to insert needle 19 into the arm or otherportion of the body of an intended recipient. To insure proper locationof needle 19, a flashback indicator 4!) is provided that may be flexedand thus aspirate blood back into the set from a vein if needle 19 is sopositioned. Flashback indicator 4 is essentially similar to connector 36and permits at any time the introduction of supplemental medication asthe occasion might require.

Where a discrete but minor amount of parenteral fluid is desired to beadministered, say 20 ml., it possible to achieve the same by clampingdevice 22 as shown by means of a hemostat 41. Since each chamber 26 ofdevice 22 contains a known quantity of fluid, it is possible in thismanner to dispense any desired incremental quantity merely by thereafteropening clamp 38 and permitting liquid outflow from the bottom portionof device 22 to set 17. It is to be appreciated that only the liquidfrom the lower portion of device 22 will be dispensed, since there willalways be liquid remaining in set 17 by virtue of the fact that the airpocket within device 20 exerts a hydrostatic force on the liquid in set17 to prevent discharge of the liquid in set 17. Only the lower portionof device 22 collapses to permit the outflow of liquid, the drip device20 being substantially rigid and maintaining its shape. Thus, the driplevel in device 20 is maintained. Further, the action of hemostat 41effectively seals the bottom portion of device 20 and set 17 againstentry of further liquid from bottle 10 or escape of air from drip device20 into bottle 10. For this purpose, the indented portions may assumethe configuration shown with very successful results. In theillustration given, the constricted neck-like portions 25 are providedby indentations 42 which are essentially V-shaped at their inner endsand which indentations provide at their outer end laterally-extendingshoulders as at 43. Laterallyextending shoulders 43 not only serve as asupport for hemostat 41, but in addition substantially limit thetendency of device 22 to balloon. Thus, exact incremental amounts offluid can be provided by the collapse of each chamber 26 of device 22.

In the course of an administration, should it be necessary to administerother incremental amounts of parenteral fluid, all that is necessary isto clamp device 22 at an appropriate constricted portion as at 44. Forthis purpose, a second hemostat (not shown) can be employed. Thereafter,by opening hemostat 41 the contents of chamber 26a (seen only in Fig. 1)can be dispensed. Removal of all hemostats from device 22 and closure ofclamp 38 permits refilling of device 22 in the manner described above.Because of the stepwise or incremental administration permitted bydevice 22, it is to be appreciated that device 22 can be favorably usedin the admisnistration of anesthetics where small discrete amounts arerequired over a period of time. In many instances, it is desirable toadmisnister an anesthetic as part of a parenteral regimen. When this isthe case, the anesthetic can be conveniently introduced into device 22through connector 36.

While, in the foregoing specification, a detailed description of theinvention has been given for the purpose of illustration, it will beapparent to those skilled in the art that numerous changes may be madein these details without departing from the spirit and scope of theinvention.

I claim:

1. In a device for sequentially delivering equal amounts of parenteralfluid from a fluid source to a tube and needle administration set, anelongated envelope constructed of two sheets of thermoplastic flexiblematerial arranged in face-to-face relation and perimetrically united,the perimetric union being interrupted at each end of said envelope toprovide fluid flow ports, a rigid fitting connected to one of said flowports and providing means for connecting said envelope to a fluidsource, the other of said flow ports being equipped with a conduitadapted to communicate said envelope with a tube ads; needleadminstration set, and removable closure means for said fitting andconduit, the longer side of said envelope being provided with aplurality of spaced, opposed, indented portions etective to define aplural' y of waistlike constricted portions adapted to be sequentiallyclamped to bring about the sequential delivery of equal amounts ofparenteral fluid.

2. The structure of claim 1, in which the said indented portions areV-shaped at their inner ends.

3. In parenteral administration equipment, a flexible lay-flat envelopeconstructed of two generally elongated sheets of thermoplastic resinousmaterial arranged in face-to-face relation and sealed together abouttheir edges, flexible tubes at each end of said envelope communicatingwith the interior of said envelope, one of said tubes being equippedwith a rigid flow fitting adapted to be coupled to a source ofparenteral fluid and the other of said tubes being adapted totelescopingly receive a second rigid flow fitting, the longer edges ofeach of said generally elongated sheets being characterized by aplurality of spaced-apart, notched-out portions, the spacing of at leastsome of said notched-out portions gradually diminishing when proceedingfrom the end equipped with said fitting to the other end of saidenvelope.

4. The structure of claim 3, in which each of said notched-out portionsis equipped with a laterally-extending shoulder.

5. In parenteral fluid administration equipment, a flexible elongatedtubular envelope equipped with flow ports at the ends thereof andadapted to collapse to a lay-flat condition, at least one integral,neck-like constricted portion in said envelope intermediate the endsthereof, one of the flow ports of said envelope being equipped with astopper-puncturing fitting, the chamber defined by said envelope betweenthe said one flow port and the said constriction portion being slightlysmaller than the chamber defined by the said envelope between the otherof said flow ports and the said constricted portion.

6. In parenteral fluid administration equipment, a flexible elongatedtubular envelope equipped with flow ports at the ends thereof andadapted to collapse to a lay-flat condition, the said envelope beingequipped with a plurality of constricted portions intermediate the endsthereof defining, with the remainder of said envelope, a plurality ofchambers, some of said chambers gradually diminishing in size from oneend to the other of said envelope.

7. In combination, a container source of parenteral fluid and a flowconduit connected at one end to said Source and equipped with needlemeans at the other end,

said source being elevated relative to said other end for gravitydispensing of fluid through said conduit, said conduit including in thelength thereof a flexible elongated tubular envelope equipped with flowports at the ends thereof and adapted to collapse to a lay-flatcondition, and at least one integral, neck-like constricted portion insaid envelope intermediate the ends thereof.

8. The structure of claim 6 in further combination with removablyattached fluid flow shutoif means, said means being operative to shutoff fluid flow through said envelope by clamping together the faces ofsaid envelope at said constricted portion.

9. In a parenteral administration system, an elevated source ofparenteral solution adapted to dispense said solution by gravity, a tubeand needle set communicating with said source for dispensing saidsolution, said tube and needle set including along the length thereof aflexible elongated tubular envelope equipped with flow ports at the endsthereof and adapted to collapse to a lay-flat condition, said envelopebeing equipped with a plurality of constricted portions intermediate theends thereof, defining, with the remainder of said envelope, a pluralityof chambers.

10. The structure of claim 9 in which the said source is equipped with apuncturable stopper and the upper of said flow ports is equipped with astopper-puncturing fitting, said fitting extending through said stopperto communicate said envelope with said source, the said envelope beingpositioned in said length adjacent said source.

References Cited in the file of this patent UNITED STATES PATENTS450,383 Wolfi Apr. 14, 1891 937,311 Leyner Oct. 19, 1909 2,483,636Hardesty Oct. 4, 1949 2,883,985 Evans Apr. 28, 1959 2,900,979 BishopAug. 25, 1959 2,907,495 Brous Oct. 6, 1959

